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J Clin Pharmacol. 2018 May;58(5):650-661. doi: 10.1002/jcph.1054. Epub 2018 Jan 19.

Obesity and Pediatric Drug Development.

Author information

1
Department of Anesthesiology, Pain, and Perioperative Medicine, Children's National Health System, Washington, DC, USA.
2
Department of Clinical Pharmacology, Children's National Health System, Washington, DC, USA.
3
Department of Gastroenterology, Children's National Health System, Washington, DC, USA.
4
School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
5
School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
6
School of Pharmacy, University of Maryland, Baltimore, MD, USA.
7
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
8
Division of Paediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland, USA.

Abstract

There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population.

KEYWORDS:

drug development; obesity; pediatrics

PMID:
29350758
DOI:
10.1002/jcph.1054
[Indexed for MEDLINE]

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